Number of patients with microdose (<2.5 millicurie; mCi) 18F-Raltegravir-related adverse events as measured by clinical observation during single intravenous dose administration and PET/MR imaging

Whole-body distribution (coronal through pelvis) of radiolabeled 18F-Raltegravir as determined by PET-MR scanning and quantification of radiographic regions of interest (ROI) immediately following and up to 4 hours after drug administration.

10

All

18 Years and older (Adult, Senior)

NCT03174977

15-17586

June 5, 2017

December 2017

December 2017

June 5, 2017

June 5, 2017

University of California, San FranciscoSan Francisco, California, United States

French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Merck Sharp & Dohme Corp.

Other / Industry

Intervention Model: Single Group Assignment

Masking: None (Open Label)

Primary Purpose: Treatment

Pharmacokinetic parameters of raltegravir in patients with severe liver dysfunction and after a liver transplantation when combined to immunosuppressive therapy. Pharmacokinetic parameters of immunosuppressive drugs with or without raltegravir

To assess the maintenance of the virological efficacy on HIV of raltegravir combined with two fully active molecules among NRTI (or NRTI + enfuvirtide). Follow-up over a 3-months period before and after transplantation

To assess the safety of raltegravir before transplantation in patients with impaired liver function, and after transplantation in combination with immunosuppressive treatment

(and 2 more...)

14

All

18 Years and older (Adult, Senior)

NCT01022476

2009-014616-36ANRS 148 LIVERAL

LIVERAL

May 2010

May 2013

May 2013

December 1, 2009

July 18, 2013

Service de Médecine Interne, Hôpital de BicêtreLE KREMLIN-BICETRE cedex, France

Platelet hyperreactivity (Platelet expression of the platelet activation marker CD62P (P-selectin) and of the activated fibrinogen receptor (αIIbβ3) following stimulation with three concentrations of the platelet agonists)

Assess Raltegravir tolerability, acceptability, and adherence among African-American men and women initiating HIV therapy. 2. Determine the pharmacokinetics of Raltegravir in African-American men and women.

Determine the pharmacokinetics of Raltegravir in African-American men and women.

38

All

18 Years and older (Adult, Senior)

NCT00667433

CID 0706

REAL

June 2008

December 2011

December 2011

April 28, 2008

March 3, 2017

The University of North Carolina at Chapel HillChapel Hill, North Carolina, United States

Wake Forest University Health SciencesWinston-Salem, North Carolina, United States